Medical and Regulatory Affairs

Clinical Research: Phase 1 - Phase 4

TrialSite News: Joining the Revolution in Dermatology Drug Development: Tips for Successful Clinical Trials

Skin diseases are the fourth leading cause of health afflictions, affecting nearly 900 million people worldwide. It’s not surprising, then, that there has recently been a noticeable increase in dermatology drug development. There are currently thousands of dermatology clinical trials planned or already launched, including a variety of programs investigating innovative, targeted therapies. Much of...

Clinical Research: Phase 1 - Phase 4

TrialSite News: Going Virtual: How to Implement mHealth and Remote Monitoring in Your Clinical Trials

In the year since COVID-19 brought all normal activity to a halt, clinical trial professionals around the world have been forced to re-examine their strategies. What happens when neither patients nor clinical research associates can visit trial sites? How can data collection and data monitoring occur — and critically, how can researchers deliver clean, concise...

Clinical Research: Phase 1 - Phase 4

5 Key Takeaways: Insights on Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies

Traditionally, Phase 1 trials commonly utilize 3+3 designs to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Studies have shown, however, that two out of three trials employing a 3+3 design failed in identifying the MTD, and better approaches are needed.1 During Premier Research’s recent webinar Alternative Designs to the...

Clinical Research: Phase 1 - Phase 4

ePremier CTMS: The Central Organizing Principle for Successful Studies

Across the industry, most trials don’t have access to real-time results…which leads to delays. 95% of those delays last longer than a month. Addressing this challenge means tackling the underlying problems of data being held in disparate places, and failure to predict and address risk. Our Premier One Ecosystem captures all the data related to...

Clinical Research: Phase 1 - Phase 4

ePremier Study Start-Up: Where a Successful Trial Launch Begins

Industry-wide, spreadsheets have long been the go-to method for tracking clinical trial start-up. Premier Research developed the Premier One Ecosystem to create a paperless, electronic data process, start to finish. Trials begin with our Study Start-Up application, which automates collection of ALL the data related to your trial, then optimizes it to decrease cycle times...

Clinical Research: Phase 1 - Phase 4

Product Development Checklist: Considerations for Each Stage of the Drug Development Process

Developing a new biopharmaceutical product is a lengthy, high-stakes journey. It takes, on average, at least 10 years and over $2 billion to successfully bring a new drug to market, and only 10% to 15% of products ultimately receive regulatory approval.[1] A comprehensive plan and the right regulatory and therapeutic expertise can significantly accelerate the...

Clinical Research: Phase 1 - Phase 4

Pathways to Expedited Drug Development in the U.S. and Europe

Preparing for expedited drug development requires a thorough understanding of the steps that comprise a successful first-in-human study. It’s essential to start with the end firmly in mind, identifying the target population and defining elements of the program long before you dose the first patient. This webinar will show you where to start and how to envision...

Clinical Research: Phase 1 - Phase 4

Key Changes in the Revised EMA Guidance on Clinical Trials During COVID

In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent...

Clinical Research: Phase 1 - Phase 4

LSX 2021: The Path From Preclinical to and Through Clinical

Presented by: Peter Larson, Vice President, Medical Affairs for Hematology-Oncology Angi Robinson, Vice President, Specialty Areas April Marquick, Cell and Gene Therapy Expert Originally presented at the 2021 LSX World Congress virtual conference, this webinar series by Premier experts in oncology, rare disease, and cell and gene therapies focuses on development considerations for advanced therapies,...

Medical and Regulatory Affairs

The Regulatory Landscape of Software as a Medical Device

So much of the medical world is about data, and as healthcare data continues to play an increasing role in the “big data” landscape, the challenge is figuring out how to use it properly within the healthcare ecosystem. A new class of medical software known as Software as a Medical Device (SaMD) is offering innovative ways to capture, optimize and analyze healthcare...